FDA Issues Order for Company to Stop Tobacco Product Sales

FDA has issued its first-ever order to stop the sale and distribution of tobacco products.

According to a press release from FDA, the agency has issued orders to stop the sale and distribution of four different tobacco products currently on the market. This marks the first time the agency has ever used authority under the Family Smoking Prevention and Tobacco Control Act to order a manufacturer to stop selling and distributing a product.

FDA has issued a manufacturer to halt production of the following products: Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone. According to FDA, these products, “were found to be not substantially equivalent to tobacco products commercially marketed as of February 15, 2007, also known as predicate products. This means they can no longer be sold or distributed in interstate commerce or imported into the United States.”

Bidis are hand-rolled cigarettes filled with tobacco and wrapped in tendu tree leaves, then tied with string. Jash International manufactures them. The company did not meet the Tobacco Control Act’s requirements. According to the press release:

“Under the Tobacco Control Act, regulated products were allowed to stay on the market if companies submitted an application to the FDA by March 22, 2011. The law requires the FDA to review product applications so the agency can decide whether the products are substantially equivalent (SE) to valid predicate products. If a company fails to provide the necessary information to show that their product is SE to a predicate product, the FDA has the authority to declare a product not substantially equivalent, which means that it can no longer be sold or distributed in interstate commerce. In this case, Jash International did not identify eligible predicate tobacco products as required for the FDA to perform an SE review.”

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • The Top 5 Safety and Technology Trends to Watch in 2019

    Get the latest on trends you can expect to hear more about in 2019, including continued growth of mobile safety applications, wearable technology, and smart PPE; autonomous vehicles; pending OSHA recordkeeping rulemaking; and increased adoption of international safety standard, ISO 45001.

  • Get the Ultimate Guide to OSHA Recordkeeping

    OSHA’s Form 300A posting deadline is February 1! Are you prepared? To help answer your key recordkeeping questions, IndustrySafe put together this guide with critical compliance information.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common training questions.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Industry Safe

OH&S Digital Edition

  • OHS Magazine Digital Edition - January 2019

    January 2019

    Featuring:

    • PREVENTING ERRORS
      Production vs. Safety 
    • EMERGENCY SHOWERS & EYEWASH
      Meeting the Requirements for Emergency Equipment
    • CONSTRUCTION SAFETY
      The State of Contractor Safety
    • FOOT PROTECTION
      The Three Keys to Effective Chemical Management
    View This Issue